Current Practice of Patients Undergoing C-arm Procedures at the Operating Department
Baseline Study on Current Practice of Patients Undergoing C-arm Procedures of Extremities or Spinal Cord at the Operating Department of the Maastricht University Medical Center+
All x-ray systems at the MUMC+ are currently operated by radiodiagnostic technicians. This is also the case for C-arms used during surgical procedures at the OR-complex. Because a gain in time efficiency is expected (i.e. not for research related reasons), a group of OR-personnel will be in-house trained to qualify for operating C-arms in low complex procedures. The shift towards C-arm procedures performed by OR personnel has been initiated also in other hospitals as it is expected to be time saving without loss of quality. However, this is an assumption and not proven by any scientific evidence. Several aspects are interesting for scientific studies as little is known about the effects of this shift on image quality, radiation dose, time efficiency and to guarantee that there is no loss of quality for the patient.
This study investigates the standard care, where radiodiagnostic technician operate the C-arms.
This study is set up such that it can serve as a baseline for a future study in which it will be assessed whether the quality of care when OR-personnel operates the C-arms is non-inferior to the standard care.
The aim of the study is to prospectively assess the standard care.
Research questions are twofold:
- What is the current practice and current time efficiency of C-arm procedures performed by radiodiagnostic technicians?
- What is the current quality of C-arm procedures operated by radiodiagnostic technicians?
調査の概要
状態
条件
研究の種類
入学 (予想される)
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- All C-arm OR-procedures performed at the OR-complex of the MUMC+;
- Type of procedure is: low complex: extremities (upper or lower), high complex: lower extremities, spinal cord (four procedure types).
Exclusion Criteria:
- No informed consent;
- Incomplete procedure information and technical parameters;
- Withdrawal of informed consent by the study patient.
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Gross and nett OR time [minutes]
時間枠:1 day
|
Measures for time efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Radiation dose (DAP[Gycm2])
時間枠:1 day
|
Measure for quality
|
1 day
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time spent by and type of personnel involved [minutes, predefined role]
時間枠:1 day
|
Measure for efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Amount of time spent inefficiently [minutes]
時間枠:1 day
|
Measure for efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Occupancy time C-arm [minutes]
時間枠:1 day
|
Measure for efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Downtime (technical failures) [minutes]
時間枠:1 day
|
Measure for efficiency, recorded by assistent investigator during research period
|
1 day
|
|
Number of revision surgeries
時間枠:1 month
|
Measure for quality, recorded by assistent investigator 1 month after the procedure
|
1 month
|
|
Radiation dose (Dose in ref_point [mGy])
時間枠:1 day
|
Measure for quality, obtained from C-arm
|
1 day
|
|
Image quality subjective scoring
時間枠:1 day
|
Measure for quality, questionaire, Likert scale 1-5 (5 being highest quality)
|
1 day
|
|
Number and type of help requests
時間枠:1 day
|
Measure of quality and efficiency, recorded by assistent investigator during procedure
|
1 day
|
|
Collimation [cm2]
時間枠:1 day
|
Measure for quality, obtained from the C-arm (= used field size)
|
1 day
|
|
Radiation related procedure time (beam on, fluoroscopy and acquisition time) [seconds]
時間枠:1 day
|
Measure for quality, obtained from the C-arm
|
1 day
|
|
Number and types of events
時間枠:1 day
|
Measure for quality, obtained from the C-arm
|
1 day
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- NL.MUMC.ORCarms
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。